Identity Imprint Knee Replacement System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Conformis Inc.

The following data is part of a premarket notification filed by Conformis Inc. with the FDA for Identity Imprint Knee Replacement System.

Pre-market Notification Details

Device IDK210191
510k NumberK210191
Device Name:Identity Imprint Knee Replacement System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Conformis Inc. 600 Technology Park Drive Billerica,  MA  01821
ContactKara Johnson
CorrespondentKara Johnson
Conformis Inc. 600 Technology Park Drive Billerica,  MA  01821
Product CodeJWH  
Subsequent Product CodeOIY
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-25
Decision Date2021-05-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M572TPS020187S011 K210191 000
M572TCR030103N011 K210191 000
M572TCR030102S011 K210191 000
M572TCR030084N011 K210191 000
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M572TCR030082S011 K210191 000
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M572TCR030073S011 K210191 000
M572TCR030073N011 K210191 000
M572TCR030072S011 K210191 000
M572TCR030103S011 K210191 000
M572TCR030104N011 K210191 000
M572TCR030122S011 K210191 000
M572TCR030163S011 K210191 000
M572TCR030162S011 K210191 000
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M572TCR030144N011 K210191 000
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M572TCR030143N011 K210191 000
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M572TCR030062S011 K210191 000
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M572TPS030184N011 K210191 000
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M572TPS030122S011 K210191 000
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M572TCR301T07S011 K210191 000
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M572TCR301T06N01 K210191 000
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M572TCR301T05S011 K210191 000
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M572TCR101F07S011 K210191 000
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M572TCR020146N011 K210191 000
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M572TCR020126N011 K210191 000
M572TCR020125S011 K210191 000
M572TCR020167S011 K210191 000
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M572TCR020147S011 K210191 000
M572TCR020146S011 K210191 000
M572TCR020127S011 K210191 000
M572TCR020126S011 K210191 000
M572TCR020107S011 K210191 000
M572TCR020106S011 K210191 000
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M572TCR020086S011 K210191 000
M572TPS020071S011 K210191 000
M572TPS020182S011 K210191 000
M572TCR020065S011 K210191 000
M572TCR020125N011 K210191 000
M572TCR020106N011 K210191 000
M572TCR020105S011 K210191 000
M572TCR020086N011 K210191 000
M572TCR020085S011 K210191 000
M572TCR020076S011 K210191 000
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M572TCR020075S011 K210191 000
M572TCR020066S011 K210191 000
M572TCR020066N011 K210191 000
M572TCR020077S011 K210191 000
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